FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

CDRH Expands Recall of BD Alaris Pump Infusion Sets

[ Price : $8.95]

FDA issues an updated alert about an ongoing Class 1 recall of certain BD Alaris Pump Module infusion sets due to device performan...

FDA Protected From Firings During Shutdown: Makary

[ Price : $8.95]

FDA commissioner Marty Makary tells agency employees that they are protected from planned mass workforce firings if a government s...

Draft Guide on Disseminated Valley Fever Treatments

[ Price : $8.95]

FDA posts a draft guidance to help drugmakers design clinical trials for treatments targeting disseminated coccidioidomycosis, als...

Larimar Reports Positive Data for Nomlabofusp

[ Price : $8.95]

Larimar Therapeutics reports encouraging long-term data from its open-label study of nomlabofusp, an investigational therapy for F...

Novo Nordisk Resubmits BLA for Once-Weekly Insulin

[ Price : $8.95]

Novo Nordisk refiles its BLA for Awiqli (insulin icodec), a once-weekly basal insulin injection for adults with Type 2 diabetes.

FDA Tells IO Biotech to Delay Cancer Vaccine Filing

[ Price : $8.95]

FDA tells IO Biotech not to submit a BLA for its experimental cancer vaccine Cylembio based on results from a recently completed P...

FDA Expands Device Early Alert Program

[ Price : $8.95]

FDA expands its medical device Early Alert program to cover all products that may pose significant safety risks.

FDA Presses for Clinical Trial Reporting Compliance

[ Price : $8.95]

CDER director George Tidmarsh urges more compliance with clinical trial reporting requirements through the Clinicaltrials.gov gate...

AbbVie Files NDA for Parkinsons Drug Tavapadon

[ Price : $8.95]

AbbVie files an NDA for tavapadon, an investigational once-daily oral therapy for Parkinsons disease.

Eyeglass Lenses OK'd for Pediatric Nearsightedness

[ Price : $8.95]

FDA grants Essilor a de novo marketing authorization for its Stellest eyeglass lenses, which are designed to both correct vision a...